Clinical trial · Interventional
Epoetin Alfa in Treating Patients With Anemia Who Are Undergoing Chemotherapy for Cancer
A Pilot Trial of Extended Interval Dosing of Epoetin Alfa (Procrit®) for the Treatment of Anemia in Oncology Patients
NCT00258440CI-TRIAL-00027441terminatedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Sponsor discontinued funding of the study
Summary
Brief summary (as posted)
RATIONALE: Epoetin alfa may cause the body to make more red blood cells. It is used to treat anemia caused by cancer and chemotherapy. It may also help relieve fatigue in patients with anemia. PURPOSE: This randomized clinical trial is studying how well epoetin alfa works in treating patients with anemia who are undergoing chemotherapy for cancer.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anemia | — | UNRESOLVED | — |
| Fatigue | — | UNRESOLVED | — |
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Interval Dosing | Drug | — | UNRESOLVED |
| Weekly procrit dosing | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Weekly Procrit (epoetin alfa) dosing
- description
- Weekly dosing schedule subjects will get the study drug once every week until the end of the study.
- interventionNames
- Drug: Weekly procrit dosing
- type
- EXPERIMENTAL
- label
- Interval Dosing (epoetin alfa) PK Group
- description
- Interval-dosing schedule subjects will get the study drug once every week until hematocrit is greater than 36% or Hemoglobin reaches a value of 12 g/dl, then they will get study drug once every other week. Subjects who consented to pharmacokinetic testing
- interventionNames
- Drug: Interval Dosing
- type
- EXPERIMENTAL
- label
- Interval Dosing (epoetin alfa) Non PK Group
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
ELIGIBILITY CRITERIA * 18 years of age or greater * Must have Hb less than 11 g/dl and normal hematopoesis * Must have non-myeloid malignancies treated with myelosuppressive therapy \*Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 * Must have a life expectancy of 6 months or greater * Must have adequate liver function (bilirubin less than or equal to 2.0 mg) and renal function (creatinine less than or equal to 2.0 mg) * Must have normal serum folate and vitamin B12 levels or be receiving replacement therapy * Must be iron replete (transferring saturation great than or equal to 20 percent and ferritin greater than or equal to 100 mg/ml) or be receiving replacement therapy * Must be able to fully comprehend and give written consent. * Female patients with reproductive potential must be practicing an effective method of birth control (e.g., abstinence, prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch, surgical sterilization) before entry and throughout the study. * Female patients with reproductive potential must have a negative serum human chorionic gonadotropin (HCG) pregnancy test at screening (within 7 days before the first dose of study drug) Exclusion criteria * Patient has uncontrolled hypertension * Patient has history of symptomatic cardiac disease * Patient has serious intercurrent illness * The patient is pregnant, has a positive serum HCG or is lactating Patient has known hypersensitivity to mammalian cell-derived products or human albumin. * Patient has diagnosis of polycythemia vera, chronic myelogenous leukemia, myelodysplastic syndrome * May not be due for transplant within 24 weeks * Anemia due to factors other than cancer. * History of a thrombotic vascular event. * History of seizures * Patient has received a red blood cell growth factor (epoetin alfa or darbepoetin) within the last 60 days
References
Publications (0)
Data not yet available
No reference posted for this study.